|
The study of sensitivity-increased effect to Anbol combined with chemotherapy to brain tumor Drug Research Center of Lonjer Abstract Clinical random controlled trial was made with
Anbol as radiate sensitivity-increased reagent. There are 41 patients with
brain tumor who entered this trial, among which 36 patients can be evaluated.
Associated group (Anbol+chemotherapy) and controlled group (chemotherapy alone)
are both 18 patients. The results in the near future indicate that complete
remission rates (CR) of associated group and controlled group are respective
50.0% and 22.2%, CR of the two groups + PR (partial remission) are respective
88.9% and 72.2% (P<0.01), Anbol has the action of improving and protecting
immunological function of patients in the chemotherapy process yet. Chemotherapy is one of the main methods of treating
malignant tumor synthetically, almost 70% of patients need to accept this kind
of therapy. But tumor for lack of oxygen cell insides has action of
antagonizing against chemotherapeutic drug, it’s easy to remain remnant focus
after chemotherapy, and this is one of the reasons of tumor reoccurrence and metastasis.
Scientists try to improve kill action to oxygen-lacked cells from hyper
pressure oxygen, increased temperature, neutron therapy, hyper-energy ray,
chemical sensitivity-increased reagent and so on for many years. There into the
study work of chemical sensitivity-increased reagent is an important field. Up
to now, there have been thousands type of chemosynthesis drug, But many of them
have problems of toxic or side effects, for example neurotoxicity[1] which
is studied most., and can’t be widely used by clinic. Medlar has the actions of nourishing liver and reinforcing
kidney, blooming energy and brightening eyes, and strengthening body [2,
3]. Animal experiments have proved that extract component of medlar—Anbol
has obvious response of enhanced chemotherapeutic sensitivity to brain tumor
[4], and can reinforce animal’s immunological function [5]. We
applied Anbol to clinic on the basis of animal experiment, and observed if
there is sensitivity-increased action combined with chemotherapy and its
influence to body immunological function in chemotherapy process. Materials and Methods
1.
Case selection: patients of brain tumor are selected as study objects,
the focus shadow of CT sheet of patient brain can be directly measured to
compare with each other. The conditions of selecting case: (1) there must be a definite
pathologic diagnosis before treatment; (2) there are chemotherapy signs of
brain tumor [3]; (3) any anti-tumor treatments have ever been
received before entering this study. 2.
Treatment methods: 41 patients with brain tumor entered the plan of this
trial from Aug, 1990 to Feb, 1992, and there are 36 patients whose data are
integrated and can be evaluated. According to the sequence of seeing a doctor,
disease phase, age, pathological type two treatment groups were randomized:
controlled group(chemotherapy alone) associated group(chemotherapy + Anbol)
include 18 patients each. Controlled group: planning project of chemotherapy
referred to the methods stated by Fletcher [7]. Patients with brain
tumor will receive chemotherapy after adopting TPB program of chemotherapy 3 to
6 course. Take a brain CT sheet when every course finished during treatment
period, and observe size change of focus. Associated group: besides above-mentioned
treatment methods, take Anbol 3g orally, 3 times each day, 30 days continuous，before
chemotherapy 2 hours on chemical days, administration lasts to the end of chemotherapy.
Brain CT sheets of the two group patients were made a present-phase effect
analyses after the end of chemotherapy. Age, sex, pathological type and
clinical staging of the two groups basically keep balanceable. 3. Observing
index and effect determination 3.1 Size of tumor: take the shadow of P-A position and lateral
position brain CT sheet as standards, evaluate according to objective effect
evaluation index of entity tumor constituted by anti-tumor medicine conference
in 1978: ① Complete remission (CR): visible tumor vanished
completely and lasted for over one month with no reoccurrence and metastasis, ② Partial remission (PR): The product of max diameter and
vertical diameter of the tumor lessened over 50%, and other focus don’t
increase size, these conditions last for more than one month; ③ Stabilization (S): the product of max diameter and
vertical diameter of the tumor lessen less than 50%, or that the tumor focus
keep unchanged and don’t increase size lasts for over one month; ④ Progress (P): The product of max diameter and vertical
diameter of any tumor that can be measured increased. 3.2 Influence on immunological function: it is
reported by Yang Ha that medlar make the immunological index of old people
convert to the level of young and health people. This article compared
conversion rate of lymphocyte measured before and after treatment of the two group
patients. Results
Effect evaluation results of 36 brain tumor can be seen in
tab 1. Total effective rate of the two groups (CP+PR), the controlled group is
72.2%, the associated group is 88.9%, and P<0.01. Tab 1
Effect evaluation of 36 patients with brain tumor after treatment
Influence of the two groups before and after
treatment on conversion rate of lymphocyte and statistic analyses of the
experiment results according to matched data can be seen in tab 2. Tab 2
Influence of lymphocytic conversion rate before and after treatment
Discussion
Scholars domestic and overseas attach importance to the
study of chemical sensitivity-increased reagent at present, although there are
many experimental reports already, many belong to chemosynthetic
sensitivity-increased reagent and the toxic reaction is very great. They can’t
be applied to clinic. Misudusuo which has been studied relatively ripe has
already applied to clinic, but it can’t be widely popularized to wide
application because of its serious nervous system toxicity [1].
Medical science of our homeland has comprehensive herb resource and rich
clinical treatment experiences; there will be wide outlook if we explore this
subject from among. But there are few studies which make chemical
sensitivity-increased study by adopting herb, this article that use medlar as
chemical sensitivity-increased reagent belongs to the first report yet. It can
be seen from clinical experiment results of this group, CR of associated group
is 50.0%, that of the controlled group is 22.2%; total effective rates (CR+PR)
of associated group and controlled group are respective 88.9% and 72.2%, there
is significant difference between the two group (P<0.05). It prompts that
Anbol combined with chemotherapy can improve the effect of brain tumor in the
near future, and this results accord with animal experiment. But because of
short experimental time, that whether long-term survival rate has been improved
need longer time follow up and observation. The drug in chemotherapy not only can kill cancer cells,
but also have damage to normal organizations meanwhile, so they show inhibition
action to immunological function [9]. The data of this group has
also proved this. Lymphocytic conversion rate of patients of single chemical
group descended from 53.4% before chemotherapy to 48.3% after chemotherapy
(P<0.05); the rate of patients of associated group rose from 41.2% before
chemotherapy to 55.8% at the end of chemotherapy (P<0.01), this shows that
Anbol has obvious protection and improvement action to body immunological
function during chemotherapy. And its action mechanism may have relationship
with big molecule polysaccharide, which can promote unspecific defense action
and specific immunologic reaction of host [10]. Anbol has no obvious toxicant and ill effect through
clinical trial observation. Only several patients have phenomenon of mucosa
dehydration in oral cavity and nasal cavity, and occasional constipation and
epistaxis, these symptoms above-mentioned will lessen when admission dose
reduce appropriately. This experiment show, as a new type of chemical
sensitivity-increased reagent, the advantage of Anbol is its light toxicity
action and strong sensitivity-increased action, and it has the value of further
in-depth study. |
|||||||||||||||||||||||||||||||||||
9.12
9.24
8.36
9.35